In the tradition of “Yes, Virginia, &c.,” DrRich once again reprises his classic holiday message.

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‘Tis once again that time of year when we Americans gather together with our extended families and friends to celebrate the Season. It is a time for catching up – renewing acquaintances and making new ones, sharing in good news and commiserating in bad, welcoming our new arrivals and mourning our losses. It is a time for giving thanks, counting our blessings, and putting our sundry individual problems into perspective. Indeed, it is perhaps most importantly a time for each of us to remind ourselves that – despite the trials and tribulations that may cause us to become relatively self-absorbed in our daily lives – we are all part of something much greater than ourselves.

So, in a way, it’s a shame we must now cull out our obese relatives and friends, and disinvite them from these joyful and fortifying reunions.

It’s not something we should do lightly, as the obese are people, too. They enjoy the holiday gatherings as much as anyone else (more, some would say, given the abundance of sugary foodstuffs which are typically provided there). But alas, excluding the obese is now something we must do – for our own sake, of course, but more importantly, for the sake of our social networks, and indeed, for America itself. For, to allow the obese to continue participating in our traditional seasonal gatherings is something we now know (as DrRich will shortly explain) to be simply too dangerous and too counterproductive to our collective interests. We can no longer permit it.

Before demonstrating why, DrRich ought to digress for just a moment to address the burning question many of his kindly and generous readers must already be asking, namely, What about Diversity?

On the surface at least, it would seem that the exulted goals of Diversity – the uber virtue, from which all the other, more subsidiary virtues must necessarily spring – would be well-served by our including the entire panoply of body types in our holiday celebrations, from the very thin to the very fat. Must we really exclude from our table our obese family and friends, whom we know and may love, while at the same time, in the name of Diversity, welcome into our collective bosom, say, self-declared Islamist terrorists who openly aim to kill us?

In a word, yes.

For the terrorist, as much a danger to our persons as he or she may pose, is merely a fervent adherent to a minority (and therefore oppressed) religious sect, whose fundamental beliefs (though they center around the utter destruction of Western Civilization) we may not legitimately place ourselves in a position to judge, and therefore, whose tolerance by us, and proximity to us, greatly enriches our appreciation of the wondrous diversity of the human experience.

In contrast, obese people are just fat.

They have no redeeming qualities whatsoever which ought to merit their protection under the beneficent umbrella of Diversity. In this way, fat people resemble Sarah-Palin-lovers, global warming skeptics, tea party fanatics (at least 40% of whom, by the way, are overweight or obese, judging from photos of their rallies), and other groups of narrow-minded or otherwise inferior people the benign tolerance of whom would quite obviously do material harm to the true goals of Diversity. But the obese pose a greater threat to us than even these other unworthies do.

And unfortunately, as we approach that charitable season in which our natural inclination would be to temporarily overlook the sins of our obese friends and relatives, to allow ourselves to fraternize with these individuals – even if only for a few brief hours during this one time of year – is to place ourselves, our non-obese loved ones, and our nation itself, in immediate and immeasurable peril.

This sad fact came to light just a few years ago when a landmark study was published in the New England Journal of Medicine proving that obesity is contagious. Merely having fat friends (and not necessarily living with or near them, or even interacting with them regularly, but merely enumerating them among your friends at a distance) can make you fat as well.

The study came from the studios of the famous Drs. Christakis and Fowler, who have embraced a software package, comprehensible only to themselves, that churns out complex images of “social networks,” from which they can derive all manner of heretofore unimagined associations. These academic stars have turned their shop into a veritable factory of peer-reviewed publications, thereby solidifying their scholarly reputations and (doubtless, now that they have done so much good for the anti-obesity movement) their ability to secure NIH grants, and other favors from government agencies.

Using data from the venerable Framingham database, these pioneers combed through old records for information about the body weight, relatives, and social contacts of individuals who were enrolled in this famous study. They then used their esoteric computer modeling software to create various “animations” depicting the evolving social relationships of the subjects, and the development of obesity, over time.

To summarize their findings: A person is 57% more likely to be come obese if a friend becomes obese, even if that friend lives hundreds of miles away. (This finding is really quite remarkable, considering that the only other natural force that acts on bodies instantaneously and at a distance is gravity. This newly discovered force that produces obesity at a distance – shall we call it “obevity?” – will have to be incorporated, with great difficulty no doubt, into the Grand Unification Theory now being sought by physicists everywhere.) The same effect was not seen when close neighbors became obese, or even (to such a great extent) when family members became obese. Furthermore, if the friendship is mutual (that is, if the fat person considers you a friend in addition to you considering the fat person a friend), the odds of your becoming obese triples. And even worse, this study shows that, even if you wisely avoid the company of fat people yourself (in an attempt to remain acceptably svelte), fat people who are acquainted with your acquaintances may still have an impact on your BMI. That is, obesity is a contagion that tends to spread throughout the social network.

So clearly, if anyone within a given social network associates with fat people, then ultimately nobody in that network is safe.

(Here is an animation the authors have provided, to show a time-lapsed view of how obesity spreads. If this doesn’t convince you, nothing will.)

Now, to be sure, there have been critics of this study – individuals, DrRich thinks, who are nearly as dangerous as the obese themselves. Since this issue is so critically important, please allow DrRich a few brief paragraphs to debunk the debunkers.

Some have complained about this landmark study because the list of “friends” employed by the authors was determined decades after the fact, from administrative records that had been used in the Framingham study for follow-up purposes, in which subjects had been asked to list relatives and a “close friend” who would know their whereabouts at all times. Critics claim that somebody who can reliably provide your contact information may be a good friend; but perhaps not. Perhaps subjects were simply more inclined to give the name of a fat person as a round-the-clock contact. After all, it’s always easier to get ahold of an obese person who, being slothful, is likely to be parked in front of his TV, popping chocolates and munching chips, than it is to contact somebody who’s thin, and is likely to be out and about, probably jogging. The researchers, in other words, were not operating from a list of BFFs, but instead from a list of acquaintences judged by the subjects at the time to be most likely available by telephone. (The subjects, remember, had been enrolled long before the era of cell phones.) So, critics insist, the baseline assumption made in this study – that the researchers actually knew who the subjects’ close friends were – is highly suspect.

To which DrRich replies: These critics likely have fat friends, and are probably even fat themselves, and thus their complaints can be dismissed with a definitive, “Bunk!”

Moving on, critics have also complained because the kind of computer modeling used in this study is not for mere mortals to understand, and therefore amounts to a black box. And indeed, DrRich must admit that the authors’ description of their statistical maneuverings is enough to make your head spin – replete as they are with the running of numerous simulations, using differing assumptions along with a quite unembarrassed manipulation of all the variables (almost as if they were seeking the “right” combination of factors to yield the desired answer, reminiscent of the scientific techniques revealed in the emails of those global warming experts). Critics go on to complain that there are only a handful of humans who claim to understand this kind of complex computer modeling, the results of which, therefore, resemble “received knowledge,” akin to what the medieval clergy used to dole out to the unwashed masses, when most people were illiterate and there were no Bibles in the vernacular.

Bunk again, says DrRich. While the computer modeling used here is indeed unfamiliar to physicians, it is very familiar to a few theoretical economists, who have used similar modelings for years in the attempt to predict the behavior of markets within social networks. DrRich even found a formal critique of the Christakis/Fowler analysis, written by two such economists (Ethan Cohen-Cole from the Federal Reserve Bank of Boston, and Jason M. Fletcher of Yale University). And while this pair of economists, in fact, concluded that Christakis/Fowler bollixed-up their analysis of obesity to such a great extent that their conclusions are completely illegitimate, DrRich counters with this query to said economists: If you know so much about computer models, how’d your investments do during the big crash in ’08? Eh?

Finally, critics say, all the reports appearing in the popular media (which often have included provocative quotes provided by Christakis and/or Fowler themselves), seem to have exaggerated the conclusions of the study way beyond what the published study actually says. For instance, all media reports stress the general contagious nature of obesity. But when one reads the study itself, one finds that the highly-publicized ability of obesity to “spread” from friend to friend actually did not hold up for the following combinations of friends: man-woman, woman-man, and woman-woman. It only reached statistical significance when both friends were men. So while the results of this study have been mercilessly generalized, in fact only one real finding was actually suggested by this data. If either you are a woman or your friend is a woman, then your friend’s obesity is not contagious to you – even if you buy the results of this study.

To this criticism DrRich responds thusly: Having fat friends makes you fat, OK? So get over it. If you choose to believe only the details of the study, instead of its spirit (as clearly expressed by the media and by the public utterances of its authors), then go ahead and enjoy your obese female friends, and see where that gets you.

The real beauty of this study is that, since it comes from a completely unique database that will never be duplicated, the data we have is the only data we’re ever going to get. So, the quibbling of the critics aside, the very best study ever conducted or that ever will be conducted on this issue shows definitively – to the satisfaction of the people that matter – that obesity is contagious.

Since the obese are rapidly becoming the witches of the 21st century, we are obligated to do everything in our power to stop them while we can. (DrRich points out that burning witches is an evil act only if you don’t believe that witches are real. If you, supported by all the respected authorities of the day, believe that real witches are present in the community, and that they indeed are capable of producing extreme harm to innocent individuals, surreptitiously and at a great distance – kind of like the obese – then burning them is at least reasonable, if not the only responsible thing to do.)

DrRich of course is not advocating burning fat people at the stake. He is already on record as saying that committing such an act would be a crime against the environment, just based on the carbon emissions alone.

But, my goodness, why would you befriend a fat person – let alone invite one into your home for a holiday supper – when doing so will put you and your family, all the way down to the second-and-even-third-degree acquaintances in your social network, at grave risk? Until the day comes when our leaders develop the courage to do what needs to be done about the menace of obesity – perhaps gathering up all the fat people and concentrating them, say, in special camps – we must do our bit to keep them from contaminating our own social networks.

As our President says, our new healthcare reforms, to be successful, will rely utterly on the straightforward and unprejudiced application of the very best medical science available, rather than on emotions, on biased opinions, or on unsupported traditions.

Until our leaders grow the teabags to begin following their own advice, let us regular folks do what needs to be done in our own homes, especially during this very special holiday season.

May God bless you and keep you – thin.

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DrRich wishes his readers a Merry Christmas and Happy New Year – whatever their BMIs – and will return here to the CRB shortly after the holidays.

In the epic debate that has played out recently between Shadowfax and DrRich over the transcendent implications of the IPAB (Independent Payment Advisory Board), Shadowfax accused DrRich of being one of those unsophisticates who refer to the IPAB  as a “death panel.”

Nothing could be further from the truth. DrRich does not use – has never used – the term “death panel” to refer to any of the multitude of expert commissions created by Obamacare, whose charge will be to dispassionately examine the scientific evidence in order to determine which patients will get what, when and how. These bodies, in fact, will be explicitly aiming to optimize the medical outcomes of the entire population (titrated to the amount of money we’re allowed to spend on healthcare), and not actively prescribing death for anyone.

Judging from the histories of governments which have adopted a collectivist philosophy, if death panels should appear on the scene they will not be aimed at determining which patients may live or die. That job, of course, will fall to the doctors at the bedside, who will offer or withhold medical services according to the dictates (i.e., “guidelines”) handed down by those sundry expert commissions. Rather, any death panels which eventually materialize will more likely be aimed at keeping those doctors themselves (and any other functionaries whose job is to do the bidding of the bureaucracy) in thrall.

So why has the term “death panel” caught on to such an extent that conservatives so often use it as shorthand to express what they see as the “sense” of Obamacare, and Progressives so often use it to accuse rational and mild-mannered critics of Obamacare (such as DrRich) of belonging to the Neanderthal persuasion?

While most would blame Sarah Palin for coming up with this unhelpful phraseology, it is DrRich’s view that President Obama himself must carry at least an equal part of the blame. If Progressives have not created death panels, they at least created the environment in which those words, when Ms. Palin first uttered them, immediately caught fire.

As readers will recall, Ms. Palin first used the fateful words, “death panels” as the Obamacare legislation was being slowly and painfully shoved through a surprisingly reluctant Democrat Congress. And as a result she caused many of our more complacent legislators to abruptly bestir themselves into a higher state of arousal, if not outright agitation. Palin’s accusation caught more than a few of them utterly unawares, and embarrassingly flatfooted.

They felt, no doubt, like they were in that dream where you unaccountably find yourself naked in a crowd. But this time, rather than reaching to hide their sadly exposed nether parts, they reached instead for their pristine copies of the monstrous Obamacare legislation which had been laid before them, and which they famously (and understandably and logically) never read. One could almost pity them, desperately rifling through the 2700 virgin pages, muttering to themselves, “Death panels? This damned thing has death panels?”

But in fact, their initial instincts were correct as regarded the advisability of actually reading the legislation. There was in truth no reason for them to waste their time. DrRich has subsequently read large swatches of the thing, and he can assure one and all that it was not designed for reading, comprehensibility, or (for that matter) imparting any actual information of any sort.

And besides, Obamacare contained no death panels, so had they read the bill they would not have discovered any. (In their state of sudden and stark panic, however, our newly-aroused legislators quickly moved to strike the section the bill that provided for end-of-life counseling, which, of course, had nothing to do with death panels.)

The very notion of death panels seems to have many supporters of Obamacare nonplussed. How can someone as inarticulate and obviously illiterate as Sarah Palin get away with accusing our highly-educated healthcare reformers of setting up such a thing as death panels?  And even more perplexingly why did so many Americans believe her – even, apparently, hundreds of thousands of Americans who had been enlightened enough to vote for President Obama less than a year earlier?

DrRich thinks it is this: When Sarah Palin said, “death panels,” she was dropping one last, tiny crystal into a supersaturated solution. Her words took what had been an amorphous and even chaotic sense of unease about healthcare reform, and immediately crystallized it into an organized latticework of directed rage and fear. So the real question is not how Sarah Palin came to be savvy enough to know just the right words. (Progressives know that even a distinguished panel of monkeys, given enough time and enough typewriters, will eventually produce King Lear.) Rather, the real question is: What put the rabble in such a supersaturated state to begin with? Why did the absurd-on-its-face idea of “death panels” so resonate with them? What made those words galvanize their shapeless disquiet into a solid mass of resistance?

DrRich is very sorry to have to tell his friends of the Progressive persuasion the sad truth. For it was President Obama himself who created this circumstance. Sarah Palin may have first named the death panels, but before she ever thought of the phrase the President had already described them in detail.

During his first year in office, President Obama offered several homilies relating just what a “death panel” would look like. He described their function, how they would operate, and who they would target. Perhaps the most instructive example is the one he gave on ABC television during his June 24, 2009 National Town Hall meeting.

DrRich refers, of course, to the famous question put to him by the granddaughter of a 100-year-old woman who had received a pacemaker. The questioner pointed out that her grandmother had badly needed this pacemaker, but had been turned down by a doctor because of her age. A second doctor, noting the patient’s alertness, zest for life, and generally youthful “spirit,” went ahead and inserted the pacemaker despite her advanced age. Her symptoms resolved, and Grandma was still doing quite well 5 years later. The question for the President was: Under Obamacare, will an elderly person’s general state of health, and her “spirit,” be taken into account when making medical decisions – or will these decisions be made according to age only?

President Obama’s answer was clear. It is really not feasible, he indicated, to take “spirit” into account. We are going to make medical decisions based on objective evidence, and not subjective impressions. If the evidence shows that some form of treatment “is not necessarily going to improve care, then at least we can let the doctors know that – you know what? – maybe this isn’t going to help; maybe you’re better off not having the surgery, but taking the pain pill.”

DrRich will give President Obama the benefit of the doubt regarding his suggestion that a 100-year-old women who needs a pacemaker might be better off with a pain pill. Mr. Obama is not actually a doctor, and cannot be expected to understand that using a “pain pill” to treat an elderly woman who is lightheaded, dizzy, weak and possibly syncopal because of a slow heart rate might justifiably be considered a form of euthanasia rather than comfort care. DrRich does not believe the President was intentionally suggesting the old woman’s death should be actively hastened by means of a pain pill. Indeed, given that repeated falls from lightheadedness would likely have led to a hip fracture, a pain pill might eventually have been just the thing for granny had the pacemaker been withheld.

Still, President Obama’s clear and unflinching answer in this case tells us several important things. 1) Under Obamacare, there will be at least one panel, or commission, or body of some sort, that is going to examine the medical evidence on how effective a certain treatment is likely to be in a certain population of patients. 2) This, let’s call it a “panel,” will “let the doctors know” whether that treatment ought to be used in those patients. (“Letting the doctor know” is a euphemism for “guidelines,” which itself is a euphemism for legally-binding and ruthlessly enforced directives.) 3) “Subjective” measures ought not to influence these treatment recommendations. Non-objective parameters – such as the doctor’s medical experience, intuition, or personal knowledge of the patient; or the patient’s “spirit,” or will to live, or likelihood of tolerating and complying with with the proposed proposed treatment; or even extenuating circumstances that might increase or decrease the success of the proposed treatment – simply cannot be evaluated or controlled by expert panels, and thus must be discounted. 4) But since our government is a compassionate and caring one, and wishes to reduce unnecessary suffering, palliative care will be made available in the form of pain control, even while withholding potentially curative care.

What the American public accurately heard the President say was that we will have an omnipotent “panel,” acting at a distance and without any specific knowledge of particular cases, that will tell a doctor whether he/she can offer a particular therapy to a particular patient – or whether, instead, to offer a “pain pill.”  His description of this process, repeated with variations over the next several months in several venues, obviously made quite an impact on the people.  Of course, Mr. Obama is widely known to be a gifted communicator.

In any case, all that remained was for Sarah Palin to give the President’s panel a catchy name. And when she did, the American people knew exactly what she was talking about. They knew, because President Obama himself had been spelling it all out for them in plenty of detail for six months.

Indeed, it seems to DrRich that, if not for President Obama’s having so carefully laid the groundwork,  Palin’s accusations of “death panels” would have fallen flat. It would have been regarded by most people as the absurdity that Progressives insist that it is, rather than the epiphany it turned out to be.

Progressives who strenuously object to its usage in reference to the expert commissions created by Obamcare can blame Sarah (or, for that matter, DrRich) if they want to – but by all rights they should actually be taking up the matter with their dear leader, who is the chief source of the misapprehension, if misapprehension there be.

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This is the first in a series of articles on End-of-Life Care and Covert Rationing.  The second article can be found here.

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It is easy to have missed it, because it went by so quickly.

On January 1, the White House announced a new policy that would have paid doctors for discussing end-of-life planning during their Medicare patients’ annual “wellness visit.” Under this policy, physicians would be paid to encourage their patients to establish an advance directive, which would guide medical care if the patient became incapacitated from illness, and could no longer make medical decisions for him/herself.

But on January 5, the new policy was suddenly revoked. It was revoked, CMS lamely explained, because it had not been implemented using the correct process. But, as anyone would know who watched Congress make Obamacare the law of the land, this could not possibly have been the real reason.

The real reason, of course, has to do with the firestorm this new policy threatened to unleash, just as the House of Representatives was about to be taken over by the cretinous opposition party.

As regular readers will recall, the Obamacare bill originally included similar language on advance directives. Physicians were supposed to urge their patients, repeatedly if necessary, to establish advance directives, and their success in extracting advance directives from their patients was to be one of the “performance measures” by which doctors would be judged to be in good or bad standing with the Central Authority.

But then Sarah Palin said “death panels,” and a furor ensued. The provision on advance directives was quickly removed from the Obamacare legislation, as if Congress was admitting that Ms. Palin had been correct and they had been caught out.* Similarly, the effort last month to reinstate the provision failed to stick for fear of criticism at a bad time.

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*The original advance directive provision in Obamacare, of course, had nothing whatsoever to do with “death panels,” since there are no panels of any sort involved in establishing advance directives. Rather, the entities that some might call death panels, and which DrRich has chosen to call GOD panels (Government Operatives Deliberating) – that is, panels of distinguished experts that will determine, by means of “guidelines,” which patients will get what, when and how – remain fully operative within Obamacare.
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DrRich has nothing against advance directives, and indeed, thinks they are a good idea – in concept, at least. Advance directives allow patients to establish beforehand, usually by a written document, what kinds of medical treatment they would or would not want should they fall victim to a serious, life-threatening illness that leaves them unable to express their wishes. Advance directives are supposed to work by providing guidance to their physicians, who, in their fiduciary capacity, are charged with acting in the patient’s best interest.

A well-constructed advance directive allows patients to choose to spare themselves from demeaning, undignified, painful or otherwise undesirable medical procedures and treatments, should they become incapacitated at a later date. “Well-constructed” implies that the advance directives are clearly and concisely written, that they honor the ethical and legal norms approved by society, and that they provide the physician with clear guidance.

But it is more difficult to write a “well-constructed” advance directive than might at first meet the eye. The major problems are two-fold: Advance directives often express imperfect knowledge, and they are often imperfectly expressed. These limitations mean that in appropriately exercising an advance directive, often the physician cannot follow them to the letter, but must interpret them according to the circumstances at hand.

A healthy and relatively robust individual cannot always know how he or she will feel years into the future, when illness strikes and it is time to exercise an advance directive. Every doctor has seen critically ill patients who, despite having advance directives to the contrary, unhesitatingly choose to be attached to a ventilator when the time comes, for instance, rather than face certain imminent death. So experienced doctors know that advance directives do not always indicate what patients will actually choose to do when the time to make a choice is upon them.

They also know that, while conscious patients have the opportunity to repeal their advance directives, unconscious or incapacitated patients do not.** So, in exercising an advance directive, the conscientious physician interprets that directive in light of many other factors, such as, her personal knowledge of the patient, the opinions of family as to what the patient would want done, and the chances of a long-term recovery if the therapy being considered is used. Then she will negotiate with responsible family members an approach that appears to meet the patient’s presumed desires.

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**Conscious patients can repeal their advance directives in theory. DrRich has witnessed actual doctors, however, arguing vociferously against using a medical therapy that a sick patient now desperately wants, because years ago the patient signed an advance directive expressing aversion to that therapy.
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Therefore the advance directive in many cases is an important part of the decision-making process, but it is not the only part. The appropriate use of an advance directive requires the doctor to behave as a true patient advocate, to selflessly place the desires expressed in the directive in context with everything else that might affect the patient’s true and current wishes, and then make a recommendation that, to the best of his or her ability, honors those wishes.

Unfortunately, doctors can no longer act primarily as their individual patient’s advocate. Indeed, physicians are officially enjoined (by the New Ethics formally adopted by their own professional organizations) to give the needs of society at least equal consideration. And so, as has demonstrably happened with other “guidelines” in medicine, it is inevitable that advance directives will be reduced to a legal edict, which must be followed to the letter if the physician wishes to remain clear of the Department of Justice.

The likelihood that there will be no room for interpretation means that constructing just the right kind of advance directive for yourself – one that will be precisely suitable to any contingency that may occur – has become extremely difficult. If you get the details just a little bit wrong for the circumstances that actually arise, the price you pay may be very heavy. It would be better to have no advance directive at all than to have one that is misleading or ambiguous. Advance directives must be written with extreme care, and only after long, thoughtful consideration.

That is not how the government would have it, however. For many years now, the Feds, under the Patient Self-Determination Act, requires hospitals to inform patients about advance directives at the time of every hospital admission, and to invite them to sign one. To say this is a less than ideal time to implement an advance directive would be something of an understatement. Asking a patient to sign an advance directive at the time of hospital admission, often by including it in the pile of routine and mind-numbing legalistic documents which patients must sign if they want to receive medical care, and often with no more guidance than that provided by the admissions clerk (who might explain, “This tells the doctors you don’t want to be kept alive on a machine like a vegetable,”) tells us something about whether the true motive for advance directives is to protect the patient’s autonomy – or to reduce costs.

Having the discussion in a doctor’s office these days, sadly, might not be much better. The Central Authority knows that squeezing what really ought to be at least a 30-minute discussion into a 10-15 minute office visit already packed with Pay for Performance requirements (while providing the added threat of punishment if the physician fails to extract an advance directive from the patient), will yield, at best, a signature on a boiler-plate document.

But despite the slap-dash method by which such a document may be implemented, it is a document whose language – when the time comes – will be exercised with all the legalistic exactitude of a contract attorney by any doctor who knows what’s good for him.

DrRich thinks that Americans are right in being suspicious of the big push they are seeing to urge advance directives upon them. Invoking “death panels” in this regard is utterly inappropriate, but the end result will suffice. It is good that we have all been given pause.

Still, the concept of advance directives is a good one, and DrRich thinks most Americans might do well to have one. Despite the damage that is being done to them, DrRich thinks advance directives can be salvaged. To this end, DrRich suggests several steps we can all take in executing an advance directive that will actually do what we want it to do:

1) Don’t be pressured into implementing an advance directive by anybody whose career depends on keeping the Central Authority happy. Unfortunately, this likely includes your doctor if you are not paying your doctor yourself.

2) Don’t sign a boiler-plate document. These likely will have been drafted with the interests of the Central Authority in mind, with the help of very smart lawyers, and when these documents are called into use in all probability they will be interpreted for the convenience of the Central Authority.

3) Try to keep your advance directive from showing up in an electronic medical record. Write it yourself, and store it where your loved ones can find it when they need it. Give a copy to your spouse, your children, and perhaps (if you have a direct-pay doctor who works only for you) your physician. This way, since your advance directive will not be immediately available to hospital personnel if you are suddenly incapacitated, no unfortunate and irreversible decisions regarding the aggressiveness of your medical care can be made until your loved ones are notified.

4) Write your advance directive as a general guideline, with as few specifics regarding particular types of medical care as possible. You should assume that any type of treatment you mention in a negative light will be withheld under any and all circumstances, including circumstances you may not be aware of in which you would want that treatment.

5) You are not writing your advance directive for the doctors (it is most tragic that we can no longer trust doctors in this regard!); you are writing it to help your loved ones make the right decisions for you, perhaps despite the doctors. So your goal should be to clarify your general desires for your loved ones. Discuss your advance directive with your loved ones after you have written it, and ideally, before you have written it. Your written words will remind them of your wishes when the time is right.

Lest you think, Dear Reader, that  DrRich is merely being sarcastic  here (and why would anyone think so?), he is not. DrRich himself has an advanced directive that attempts to follow these rules. The document is stored at home with his important papers. Mrs. DrRich knows where to find it, and knows DrRich’s general feelings regarding these matters. With the guidance he has provided, DrRich trusts her and his children to make these important decisions for him. For anyone who is interested, DrRich’s advance directive is reproduced, in its entirety, at the end of this post. (The general language, which has been adapted and revised by DrRich for his own use, was originally suggested to him by a good friend who is a superb internal medicine practitioner.)

So. Advance directives are a very good idea, but unfortunately, have been identified by the Central Authority as a potentially powerful cost-cutting tool. Even before Obamacare, certain HMOs were refusing to reimburse hospitals or doctors that provided medical care that seemed to go against specific language contained in an advance directive. That, of course, was child’s play. Now that the Central Authority has gotten hold of them, advance directives will likely be treated the same way as other guidelines are now treated in medicine, that is, as edicts, and thus as vehicles for the criminal prosecution of medical personnel who deign to “interpret” them.

This means that if you wish to take advantage of the benefits which advance directives can provide, you will have to proceed very, very carefully.

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DrRich’s Advance Directive:

If I am able to communicate my wishes by any means whatsoever, then I wish to make my own decisions regarding my own healthcare. If, despite my ability to communicate, my condition makes it inconvenient to fully inform me of my situation and all my treatment options, then until such time as it becomes sufficiently convenient to do so, I want everything possible to be done to sustain my life and effect a recovery.

In the event of an incapacitating illness in which I cannot communicate, the basic guideline initially should be to do everything possible to sustain my life and effect a recovery.

After a reasonable period of time (in general, I would consider a week to be reasonable) if no progress has been made in the recovery of my mental function, and the likelihood of mental recovery is judged to be small, then withdrawal of life-sustaining care should be strongly considered. To help my wife and/or children with this decision, I would like to have an evaluation by a neurologist to help clarify the prognosis.

If improvement in my mental status has been made, then efforts to sustain my life and affect a recovery should be continued.

If at any point in my care there is a period of at least two weeks in which I am persistently unable to carry out meaningful communications sufficient to make my own wishes known (in the opinion of my family members and the neurologist), and the likelihood of mental recovery is judged to be small, then I would consider the withdrawal of life-sustaining care to be a blessing.

In his last post, DrRich suggested that the Guideline Wars (i.e. the bloody battles over who gets to establish the patient-care guidelines that determine which patients will get which medical services, and which medical specialists will get to provide them) are about to enter the Obamacare phase, in which those who make the guidelines will no longer be medical professional organizations, but agents of the federal government. DrRich helpfully labeled the various guideline panels provided for by the Obamacare legislation as the “GOD panels” (for Government Operatives Deliberating), in order to avoid using the more inflammatory “death panels” terminology favored by certain less sophisticated commentators.

In addition, DrRich pointed out that his own tribe of medical specialists – the cardiologists – may perhaps be in a better position than most other physician tribes to manipulate the deliberations of these GOD panelists. The cardiologists would attempt such manipulations, DrRich suggested, by “pre-spinning” certain critical data from clinical trials, before that data is taken up by the government panels.

From their long experience in fighting the Guideline Wars, cardiologists understand that data from clinical science does not invariably lead to a fixed conclusion (as most proponents of evidence-based medicine seem to believe), but rather, can often be shaped into whatever sort of conclusion one might want to reach. Just as different primitive cultures discerned different constellations when they looked up into the same night sky, so will different groups of experts come to different conclusions when they look at the same clinical data.

Accordingly (DrRich submits), cardiologists have already embarked on the task of pre-spinning the data, such that when the GOD panelists look for the first time up into the vast and chaotic sky of clinical evidence, they will have in hand a map of the constellations as seen by the cardiologists.

To illustrate what he means, DrRich calls his readers’ attention to the SYNTAX trial, a clinical trial designed by cardiologists and their industry partners for the purpose of reaching a specific conclusion, but which (unfortunately for cardiologists) reached the opposite conclusion. If the data from the SYNTAX trial should ever fall into the hands of the GOD panelists (or any other guideline panels) in a pristine fashion, it could spell disaster. So the cardiologists have spent nearly two years attempting to make the data say what they want it to say, and today, after continuously massaging the data, issuing press release after press release, making presentation after presentation, and publishing academic paper after academic paper, it would be at least a little surprising if the God panelists, surveying this body of pre-spun data, would fail to produce clinical guidelines which provide the cardiologists at least some of what they’re after.

The SYNTAX trial randomized 1800 patients with complex coronary artery disease (i.e., CAD that produces either significant blockage in the left main coronary artery, or severe triple-vessel disease) to therapy with either bypass surgery or drug-eluting stents (DES), and assessed their long-term outcomes.

In general, patients with stable CAD (i.e., those who are not currently having a heart attack or unstable angina) do just as well with aggressive medical therapy as they do with invasive therapy. People like the ones enrolled in SYNTAX, however, are the exception to this rule. That is, patients with either of these two specific patterns of complex CAD have been shown to have improved survival if they receive bypass surgery. Indeed, these patients represent a virtual “last stand” for cardiac surgeons – they are nearly the only patients cardiologists (at least some cardiologists) still feel obligated to refer for bypass surgery. And, as one might expect, in their decades-long turf war with cardiac surgeons (a war from which they will not desist until they see the great majority of cardiac surgeons seeking jobs as beer vendors at sporting events), cardiologists have long chafed at this singular remaining obligation to refer.

Accordingly, SYNTAX, a study instigated by cardiologists and sponsored by Boston Scientific (a manufacturer of DES), was intended to show that with modern cardiac stents, stenting yields outcomes that are not significantly inferior to bypass surgery in these patients. Specifically, that is, SYNTAX was designed as a “non-inferiority trial.” This was certainly a modest goal – some might say too modest – but a positive result would enable cardiologists (the gatekeepers to all invasive CAD therapy) to simply keep these patients for themselves, just as they now do with all the other CAD patients. The SYNTAX trial asked the question, “Do I really have to refer these patients to the cardiac surgeon?” And the desired answer was, “No, it apparently is not statistically provable that you absolutely have to refer them, one supposes.” Judging from the study design, that answer would have been plenty rigorous enough for the study designers.

Alas, however, when the one-year follow-up data for the SYNTAX study was analyzed, the results turned out to be negative; stenting was significantly inferior to surgery. The endpoint of the study was a composite called MACCE (Major Adverse Cardiac and Cerebrovascular Events), and in this study included death, heart attack, stroke, and the need for more revascularization procedures. The bottom line is that in SYNTAX, the risk of MACCE was significantly higher for stenting than for bypass surgery. The study failed to meet even the modest non-inferiority goal the cardiologists had devised for it.

The one-year data for the SYNTAX trial was published in the spring of 2009 in the New England Journal of Medicine, just as the battle over healthcare reform was taking shape, and nearly six months after Sarah Palin had reported her mysterious vision of death panels. But whether one wanted to call them death panels, GOD panels, or panels of distinguished monkeys, it was clear by the time SYNTAX was published that the government, and no longer the physicians’ own specialist organizations, would be manufacturing all clinical guidelines in the near future. So disaster loomed.

But, the cardiology community quickly rallied, and launched into a concerted effort to spin the results of SYNTAX from a disaster into a victory, or at least, to something akin to victory. And the efforts of the cardiologists in this regard have been impressive over the last 18 months.

Within minutes of the publication of the original SYNTAX article, scores of press releases were launched, and scores of “experts” were dispatched to give interviews, implying that the SYNTAX study was a major, ground-breaking victory for stenting.

For instance, here’s the link to an article in the New York Times (subsequently reproduced in hundreds of newspapers around the country) entitled, “Heart Stents Found As Effective As Bypass For Many Patients.”

And here’s a triumphant press release from Boston Scientific, the study’s sponsor, in which the negative overall results of SYNTAX are buried deep within the 6th paragraph (following all kinds of positive-sounding fluff), and are difficult to locate even if you are specifically looking for them.

And here’s the more-than-triumphant press release from one of the leading clinical sites for the SYNTAX trial, which reads, in part:

“At NorthShore, we experienced stunning outcomes [emphasis DrRich's] in patients whose only option would have previously been bypass surgery,” said Ted Feldman, M.D, F.S.C.A.I., Director of Cardiac Catheterization Laboratory, NorthShore University HealthSystem, and a lead investigator of the trial. “The data in this study will provide cardiologists with additional information as they determine treatment therapy for patients with complex CAD.”

Most remarkable of all, we have the spectacle of the lead author of the SYNTAX paper, Dr Patrick W Serruys himself, telling Heartwire immediately after publication of the paper, that the paper’s concluding sentence (i.e., “CABG as compared with PCI is associated with a lower rate of MACCE at one year among patients with three-vessel or left main coronary artery disease (or both) and should therefore remain the standard of care for such patients.”), is just plain wrong. Serruys declared that this concluding sentence actually “is not the essence of the trial.” He only allowed that concluding sentence to appear in the paper, he said, “because the New England Journal of Medicine wanted something more conservative.” (Apparently, having the paper appear in a prestigious journal overrode the necessity of having the paper accurately reflect what the authors meant to say.)

In any case, Serruys insisted (despite the conclusion expressed in his ink-not-yet-dry paper) that many patients like the ones enrolled in the SYNTAX trial can safely be treated with stents, and indeed, he announced that he and his co-investigators were hard at work teasing apart the SYNTAX data in order to develop a so-called “SYNTAX score,” that would help cardiologists determine which patients they can treat themselves, without referring them for surgery. So indeed, despite the negative results, and despite the conclusion written in their own paper, the SYNTAX trial was immediately spun by key trial participants themselves into a win (while not a complete victory, still a win).

Before his readers come down too hard on the cardiologists for such behavior, DrRich feels obligated to point out a partially mitigating truth. Namely, cardiologists believe to the depths of their souls, notwithstanding the largely negative body of medical literature to the contrary, that stenting coronary artery blockages – in virtually any configuration and any clinical situation – saves lives. And if they haven’t been able to prove that yet, it’s just because of the vagaries of clinical research. One must not let spurious results from imperfect research block the Truth, lest one allow great harm to come to humanity.

The results of the SYNTAX trial must simply be wrong, cardiologists believe, and so they would be gravely harming patients if they did not take whatever steps were necessary to render the results of SYNTAX more favorable to stenting. To do otherwise would cause thousands of clinicians to make inappropriate decisions.

In this way, DrRich believes, cardiologists are no more guilty than are Progressives, another category of humans who believe with their hearts and souls in something that is simply not true (in the case of Progressives, that the great mass of humanity will willingly suppress their own individual interests in favor of the interests of the collective). Like the Progressives, cardiologists are often very nice, well-meaning, sensitive and compassionate individuals, and some of them would even be fun to go out with for a beer.

In other words, DrRich pleads, cardiologists are not being particularly evil in spinning the SYNTAX trial results; they are simply doing what comes naturally, and what they deeply believe to be the right thing.

This is why the SYNTAX investigators were convinced that, buried within the vast body of clinical data the SYNTAX trial has generated, there simply MUST be something useful to cardiologists. Accordingly, the SYNTAX investigators dived head-first into the proverbial room full of manure, enthusiastically digging for the pony which simply must be in there somewhere.

And indeed they quickly found their pony.

And here it is: While a straightforward analysis of the SYNTAX study shows that bypass surgery wins hands down over stenting, if one delves a bit deeper into the data, one finds that one of the components of the MACCE endpoint – the incidence of stroke – was statistically higher among the patients randomized to bypass surgery. One also finds that the incidence of needing revascularization during follow-up was higher in the stent patients. So, taking these two interesting observations together, the cardiologsts have concluded that patients receiving bypass surgery are trading a reduced need for subsequent revascularization for an increased risk of stroke – a bad trade indeed. Therefore, despite the overall results of the study, they have concluded that stents are better than bypass surgery for at least some patients. (And they promised to discover for us, during the data-mining exercise from which their “SYNTAX score” was subsequently invented, which patients those are.)

And this – the reduced incidence of stroke seen in the stent patients – is the basis for the celebratory statements which were issued by the SYNTAX investigators upon publication of their original paper.

DrRich agrees that, as a general proposition, he would probably rather have an extra invasive cardiac procedure than a stroke, and suspects that most people would say the same thing. But before we all buy what cardiologists are selling here, DrRich would like to make a few observations.

First, the results of the SYNTAX trial are the results. Stenting did not meet even its modest non-inferiority endpoint, and it failed to meet it by quite a lot. Once the pre-designated endpoint of a randomized clinical trial is determined, any remaining observations that can be gleaned from the large amounts of data invariably generated by such trials must be viewed as inconclusive, as merely hypothesis-generating. Such observations are not to be regarded as having sufficient statistical surety to vastly change medical practice, or to figure into evidence-based guidelines. So, another clinical study would need to be conducted to prove the hypothesis that strokes are less frequent with stenting than with bypass surgery in patients like these.

Similarly, the “SYNTAX score” – which indeed was generated and subsequently published as a “guide” for cardiologists treating patients with complex CAD, and which is therefore presumably being used today by cardiologists all over the world to select which of these complex patients they can just go ahead and stent rather than refer for bypass surgery – has no business being incorporated into clinical practice. An exercise like this – in which investigators comb retrospectively through the clinical data, selecting out patients who had good results with stenting, then devising a group of characteristics that appears to differentiate them from those who did not – cannot possibly yield a validated, widely-applicable clinical tool. If they want to claim that their SYNTAX score is clinically useful, they need to conduct another randomized clinical trial to test that hypothesis.

Next, and most remarkably, there’s the almost universally-ignored fact (reported by Dr Friedrich W Mohr, co-principle investigator of the trial), that among patients assigned to bypass surgery in the SYNTAX trial who experienced a stroke, nearly half of them had their strokes PRIOR TO SURGERY. What this means is that, in reality, the bypass surgery itself did not cause those strokes, a fact that ought to cause serious damage to the chief assertion of the stent-proponents. This fact alone turns their pony into a pig. The claim that stenting instead of surgery would have avoided these strokes is largely, if not entirely, spurious. Indeed, if anything, the fact that patients “randomized” to surgery apparently had a lot of strokes in the brief period of time between the act of randomization and the surgery itself ought to make one question whether the selection of therapy was really and truly random, or whether, somehow, patients who looked particularly sick got sent preferentially to the surgeons.

And finally, the clinical choice as it has been starkly painted by many proponents of stenting – that the real trade-off in choosing between stenting and bypass surgery in these patients is the choice between the higher risk of stroke with surgery versus the higher risk of revascularization with stenting – is incomplete and misleading. Presenting the choice in this way clearly favors stenting, and this presentation entirely explains the positive press releases and subsequent media coverage of the SYNTAX trial. But this is not a valid comparison of risks for several reasons:

1) As noted above, the actual risk of stroke posed by performing bypass surgery in the SYNTAX trial has been substantially overstated for public consumption (by implying that the surgery caused those strokes, when half occurred prior to surgery).

2) Surgeons in the SYNTAX trial most often did not employ newer techniques now in routine use, such as off-pump surgery and LIMA grafts, both of which can substantially reduce the risk of stroke and other embolic phenomena.

3) Re-occlusion of the involved arteries (which occurred about equally in both groups in this study, and which spokespersons for SYNTAX seem to brush off as not such a big deal), is an entirely different phenomenon in patients who have received DES than it is in patients who have had bypass surgery. After bypass surgery, re-occlusion tends to occur gradually, and the patient generally experiences recurrent symptoms of angina. But in DES, re-occlusion much more commonly occurs acutely, and catastrophically, leading rapidly to permanent cardiac damage and often, to sudden death.

4) Item # 3 might explain why the composite endpoint of “death, heart attack and stroke” was equal in both groups, even though stroke was significantly higher in the surgery group. That is, in order for the math to work out, the remaining dyad of “death and heart attack” necessarily must have been higher in the stent group. As far as DrRich can tell, this point has never been discussed in public.

5) In order to avoid the catastrophic re-occlusions seen with DES, cardiologists now insist that their DES patients take long-term, even life-long, Plavix, a powerful blood thinner. As the purveyor of a patient-oriented website on heart disease, DrRich cannot tell you how many distressed and stented-up patients have written to him with the following lament:

“My doctor put in one of those drug coated stents and has me on Plavix. He says if I stop the Plavix I could die, and won’t let me stop it for any reason. But I need my gallbladder out because I keep having gallbladder attacks, and the last one gave me blood poisoning. My surgeon says I need the surgery but he won’t do it unless I stop Plavix, and my cardiologist says no stopping the Plavix for any reason. What can I do? Can they just take these stents out so I can stop the Plavix?”

There is no easy answer to this question, at least not that DrRich can find. The DES patient commonly is left in the middle of a pissing match between surgeon and cardiologist. The fear of the cardiologist is that when one stops Plavix, there is a risk of sudden, catastrophic thrombosis of the coronary artery. But surgeons simply cannot operate safely on patients taking this drug. Few cardiologists seem to explain this to their patients before placing DES.

And more to the point at hand, none of the cardiologists spinning the SYNTAX trial are explaining to the public the implications of long-term Plavix. Even if their claims that stenting yields significantly fewer strokes turned out to be accurate, the choice here is clearly NOT a simple one between a higher risk of stroke on one hand, and a higher risk of needing “revascularization” (if they survive the re-occlusion, that is) on the other. There’s a lot more to think about than that, and cardiologists who imply otherwise are being either disingenuous, or delusional.

Just last week, SYNTAX investigators reported on the three-year outcomes in patients enrolled in the trial. The results, similar to the one-year outcomes, remain strongly in favor of bypass surgery at three years, and indeed, the incidence of stroke in stented patients has “caught up” with the incidence of stroke in the surgery patients.

This persistently bad news still does not really phase the cardiologists, who are now saying that the results of SYNTAX don’t really apply any more in any case, because drug-eluting stents have been improved since the trial was done.

It would appear that the cardiologists are going for some sort of official announcement to the effect that that the results of SYNTAX are, for practical purposes, indeterminate, and that what is needed is a new clinical trial, in which patients randomized to DES will receive the latest generation of stents. (Since there is a new generation of stents every year or so, this entire process can be repeated as needed until the cardiologists finally get the results they’re looking for, at which point they can declare final victory and stop.)

Summary:

All medical specialists should take a lesson from the cardiologists. In an era in which specialist organizations will no longer be writing the clinical guidelines for their own specialty, it is necessary to aggressively pre-spin any important clinical data upon which the GOD panels will be deliberating.

Considering the SYNTAX trial as a case study, one sees how it is possible to take the most straightforward results from a very straightforward clinical trial and, if not turn a negative outcome into a positive one, at least introduce enough complications, nuance, spin and uncertainty to cause any self-respecting GOD panelist to hesitate in making a definitive pronouncement on those results. Then, if you couple all the uncertainty you’ve created with a loud call for yet another clinical trial – one that will take into account new equipment, new techniques, new scoring systems &c., and that promises to clear up all the confusion you’ve dug up as a result of the last clinical trial – then you stand a decent chance of at least getting a postponement on any new guidelines harmful to your cause.

And this, you neurologists, gastroenterologists, pulmonologists and all you other, less savvy medical specialists, is how one can manage the GOD panels.